* House Democrats seek probe but Republican chairman mum
* Massachusetts lawmaker pledges bill to strengthen FDA
* Senators request briefing with FDA, CDC staff
WASHINGTON, Oct 9 (Reuters) - Congressional Democrats on
Tuesday called for a probe of a deadly meningitis outbreak in
nine states, raising questions on issues ranging from the timing
of the official response to the possible role of health insurers
including Medicare.
The outbreak, which may have exposed as many as 13,000
people to tainted steroid injections for back and joint pain,
could pose a challenge for Congress in the partisan pre-election
atmosphere and as it faces a post-ballot fight over healthcare
spending in deficit-reduction talks.
Lawmakers in both the House of Representatives and the
Senate appear to be moving slowly on the issue so far.
At the center of the crisis is a Framingham,
Massachusetts-based pharmacy involved in the largely unregulated
practice of drug compounding, or altering approved medicines to
meet the special needs of doctors and their patients. Health
officials said on Tuesday that 11 people had died and 119 had
been sickened by the contaminated drugs.
In a letter to the Republican chairman of the House Energy
and Commerce Committee, three Democrats questioned whether
efforts to identify the source of the outbreak were delayed by
confusion surrounding the U.S. Food and Drug Administration's
authority over compounding pharmacies.
"This incident raises serious concerns about the scope of
the practice of pharmacy compounding in the United States and
the current patchwork of federal and state laws," wrote the
panel's top Democrat, Representative Henry Waxman, who was
joined by fellow members Frank Pallone and Diana DeGette.
They also expressed concern that some healthcare providers
may have purchased the tainted treatments at a low price and
then received full compensation from private health insurers and
Medicare, the government healthcare program for the elderly and
disabled.
A fourth Democrat, Edward Markey, whose Massachusetts
district includes Framingham, said separately that he would
introduce legislation to strengthen the FDA's regulatory
authority.
The office of the House oversight committee's Republican
chairman, Fred Upton, did not return phone calls or emails
seeking comment.
SMALL MANUFACTURER
Democratic Senator Richard Blumenthal has called for a
meningitis investigation by the Senate Health, Education, Labor
and Pensions Committee, saying new legislation is needed.
That panel's Democratic chairman and Republican ranking
member have instead requested a briefing with the staff from FDA
and the U.S. Centers for Disease Control to determine what
action, if any, Congress should take.
One Republican, Senator Richard Burr, issued a statement on
Tuesday acknowledging that the outbreak raises important
regulatory questions. But he stopped short of Blumenthal's call
for a Senate probe and official hearings.
The three House Democrats said the pharmacy at the center of
the outbreak, the New England Compounding Center, appeared to
stray far beyond a legal exemption for pharmacists that allows
them to provide customized doses of medicine to individual
patients.
Instead the lawmakers said NECC operated like a
manufacturer, shipping more than 17,000 vials of compounded
steroid injections to customers at 76 facilities in 23 states.
"Congress ... did not intend for a compounding pharmacy to
be permitted to operate as a small drug manufacturer," the
lawmakers wrote.
Compounding is not subject to the safety and efficacy
standards that FDA requires of drug manufacturers. Legal and
public health experts say that creates a regulatory loophole for
operators seeking to boost profits by compounding large volumes
of drugs at prices far below those of FDA-approved products sold
by manufacturers.
The regulatory question is also at the heart of conflicting
federal court rulings on the FDA's ability to scrutinize
compounding pharmacies. Experts say the cases pose issues that
may need to be settled by the U.S. Supreme Court.
The Democrats asked whether the FDA knew of the scope of
NECC operations and whether the agency had clear authority to
act.
They also raised questions about whether Massachusetts
health officials took steps to ensure the safety of NECC
products following earlier problems addressed by a 2006 consent
agreement.
According to the letter, Congressional officials should also
determine if there were legitimate scientific reasons for using
the steroid treatment and whether patients and doctors were
aware that the products were produced by compounding.
